—#48718

Product

Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom sterile packs were packaged with the bulk, non-sterile drapes and then the complete custom pack was sterilized; packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085; identified by the following catalog numbers: a) SVC13AMEMK - Sterile Open Heart Adult Pk; b) SCV31OHMPJ - Sterile Open Heart w Drapes Pk; c) SVC42OPVCG - Sterile Open Heart Adult Pack; d) SCV32CPMUO - Sterile CAB 146060 Pack; e) SCV34OHTMJ - Sterile Basin Pack; f) SCV31LVLUM - Sterile Liver Transplant Pack; g) SCV19CVHHF - Sterile Cardiovascular Pack; h) SCV11ADLLD - Sterile Open Heart/Adult; i) SCV92CBHRB - Sterile CABG Pack; j) SCV92CASIA - Sterile Cardiovascular Pack; k) SBA32GSMUL - Sterile General Surgery Pack; l) SCV30OHKWA - Strl **** Open Heart Pack; m) SBA31LVLUM - Sterile Liver Transplant Pack; n) SBA35LTBLQ - Sterile Lung Transplant Pack; o) SCV44CVDEB - Sterile CV Pack; p) SCV22OHMES - Open Heart Pack; q) SCV23AOSFH - Open Heart Part 3; r) SCV43OHHRF - Open Heart; s) SCV24CAGME - CABG Drape Pack; t) SAN12CCKGB - Cardiac Pack; u) SBA13BRBSE - Breast Reduction; v) SCV11CBNYP - CABG G 3; w) SCV11CESLB - C.V. Drape Pack; x) SCV11CGCPR - CABG; y) SCV11CGXXB - CABG Pack; z) SCV11CJICL - Cardiac Major; aa) SCV11CTMUK - C T Set Up; bb) SCV11DPMYG - **** S Drape Pack; cc) SCV11HEMMI - Open Heart A B; dd) SCV11MRCPE - Major Cardiac; ee) SCV11OCNYN - OH CABG; ff) SCV11OHLD2 - Open Heart A&B Pack; gg) SCV11OHNMC - Open Heart; hh) SCV11OPLKC - O P CABG; ii) SCV11VASLB - C V Valve Drape; jj) SCV11VLNYM - G 3 Valve; kk) SCV12OHYHY - Graft and Linen; ll) SCV13AABSV - Aortic Aneurysm; mm) SCV13AMEMJ - Open Heart Pack B; nn) SCV13BBEMC - Cardio-Thoracic Aux; oo) SCV13CB767 - CABG; pp) SCV13OHCAI - Open Heart Pk; qq) SCV13OOBIG - Open Heart Drape; rr) SCV14O1BGO - Open Heart Pack A; ss) SCV22OHPGA - Open Heart Pack; tt) SCV22OOMSE - Open Heart Preferred; uu) SCV24OH20A - Open Heart Drape Pack; vv) SCV43DREJI - Open Heart Drape Pack; ww) SCV69OH17E - Open Heart; xx) SCV59HVSGJ - Heart Valve Pack; yy) SCV59OHNVM - Open Heart Pack; zz) SCV53HTDMG - ***** Open Heart; aaa) SCV56CH11A - Open Heart Pack; bbb) SCV59MJTCW - Open Heart Pack; ccc) SCV52OH97F - Open Heart Pack; ddd) SCV41OHHIE - Open Heart Pack; eee) SCV52HTSJE - Open Heart Pack; fff) SCV59OHMHV - Basic Heart Pack; ggg) SCV11MJTJI - Open Heart

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: cat #SVC13AMEMK, order #777594; cat #SCV31OHMPJ, order #773933; cat #SVC42OPVCG, order #774231; cat #SCV32CPMUO, order #774845; cat #SCV34OHTMJ, order #775103; cat #SCV31LVLUM, order #775646; cat #SCV19CVHHF, order #776102; cat #SCV11ADLLD, order #776475; cat #SCV92CBHRB, order #776785; cat #SCV92CASIA, order #776792; cat #SBA32GSMUL, order #777047; cat #SCV30OHKWA, order #777171; cat #SBA31LVLUM, order #777288; cat #SBA35LTBLQ, order #777599; cat #SCV44CVDEB, order #780376; cat #SCV22OHMES, order #731809; cat #SCV23AOSFH, order #737659; cat #SCV43OHHRF, order #739410; cat #SCV24CAGME, order #740765; cat #SAN12CCKGB, order #732285; cat #SBA13BRBSE, order #731714; cat #SCV11CBNYP, order #732629; cat #SCV11CESLB, order #734779; cat #SCV11CGCPR, order #732923; cat #SCV11CGXXB, order #735832; cat #SCV11CJICL, order #735189; cat #SCV11CTMUK, order #734463; cat #SCV11DPMYG, order #732152; cat #SCV11HEMMI, order #733639; cat #SCV11MRCPE, order #733157; cat #SCV11OCNYN, order #732625; cat #SCV11OHLD2, order #732191; cat #SCV11OHNMC, order #732446; cat #SCV11OPLKC, order #735134; cat #SCV11VASLB, order #737823; cat #SCV11VLNYM, order #732656; cat #SCV12OHYHY, order #735934, 734739, 732575; cat #SCV13AABSV, order #732913; cat #SCV13AMEMJ, order #732970; cat #SCV13BBEMC, order #732070; cat #SCV13CB767, order #732869; cat #SCV13OHCAI, order #733777, 731664; cat #SCV13OOBIG, order #734407; cat #SCV14O1BGO, order #738338; cat #SCV22OHPGA, order #735643; cat #SCV22OOMSE, order #738400; cat #SCV24OH20A, order #735637; cat #SCV43DREJI, order #741763; cat #SCV69OH17E, order #975704; cat #SCV59HVSGJ, order #975779; cat #SCV59OHNVM, order #976192; cat #SCV53HTDMG, order #976853; cat #SCV56CH11A, order #977429; cat #SCV59MJTCW, order #977839, 978730; cat #SCV52OH97F, order #978285; cat #SCV41OHHIE, order #978409; cat #SCV52HTSJE, order #978410; cat #SCV59OHMHV, order #978523; cat #SCV11MJTJI, order 737814

Why it was recalled

The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.

Root cause (FDA determination)

Other

Action the firm took

Cardinal Health sent separate recall letters dated 9/27/06 via UPS next day delivery to those accounts who ordered the drapes alone and those accounts who ordered custom sterile packs and PBDS modules, informing them that the cardiovascular split drapes may tear and/or fray at the reinforced fenestrated trough area during use. The letters listed the catalog numbers and affected lot numbers of the sterile drapes, and the letters sent to the pack and module customers were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to inspect their inventory to determine if they had any of the affected product on hand; segregate the affected inventories; complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of drapes in inventory being destroyed; and contact the El Paso Customer Service Center at 915-779-3681 to order replacement product. Distributors were requested to notify their customers of the recall. An additional letter dated 10/25/06 was sent via UPS overnight delivery to 49 of the accounts, expanding the recall to include lot 06HRD110 of catalog #9158, Convertors Tiburon Cardiovascular Split Drape II, Sterile. The instructions remained the same as those in the 9/27/06 letter.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726

Distribution

Distribution pattern: Worldwide Distribution- USA and countries of Kuwait and Australia

Timeline

Recall initiated: 2006-09-27
Posted by FDA: 2006-10-21
Terminated: 2008-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48718. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.